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Prospective Evaluations of Infectious Complication in Lung Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00177918
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
EJ Kwak, University of Pittsburgh

Study Description
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Brief Summary:
The primary aim of this study is to determine prospectively the viral and C. pneumoniae infection prevalence and outcomes of infections in lung transplant recipients. The study will also determine the correlation of C. pneumoniae infection with the development of obliterans in lung transplant recipients.

Condition or disease
Disorder Related to Lung Transplantation Bronchiolitis Obliterans

Detailed Description:
This is a prospective cohort study of lung transplant recipients and those who will undergo lung transplantation. Patients will be identified by the pulmonologist performing the bronchoscopy. The patient's sera (obtained from a one time blood draw of 10 milliliters - two tablespoons) and cell pellet of BAL will be frozen at -70º C. Once the active or non- OB status is determined by the pathologist, stored BAL fluid (cell pellet) will be analyzed. C.pneumoniae serum titers will also be measured and compared with stored pre-transplant sera. Left over cell pellet of the BAL fluid will be used to measure the presence of C. pneumoniae by PCR method. Additionally PCR will be performed for other viruses (CMV, EBV, HHV6 & 7, human metapneumo virus and human rhino virus). In addition, during the bronchoscopy procedure as part of the patient's standard of care, a biopsy is obtained. This is done during the bronchoscopy procedure. The tissue is then sent to the pathology lab. We will collect residual (excess) tissue samples to perform research related testing. This testing will determine if we can predict other types of infections and early onset of rejection. These determinations will assist clinicians in administering appropriate dosage levels of antibiotics required to prevent or treat infections and help stop the rejection process. The subject will be asked a few questions about pulmonary symptoms that will not take more than five minutes by one of the investigators or study coordinator. The subject's medical record will be reviewed for demographic information (age, sex, and race), lab results (standard to post transplant care), medication information, as well as any testing/procedures during the transplant follow-up period. This information and results of the tests/procedures will become part of the research record.
Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluations of Infectious Complications in Lung Transplant Recipients
Study Start Date : August 2006
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
lung transplant patients


Outcome Measures
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Primary Outcome Measures :
  1. long term outcome after lung transplantation [ Time Frame: five year follow up ]
    looking at death rate five years post lung transplantation


Biospecimen Retention:   Samples Without DNA
All biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers will be removed and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. All samples that are provided to outside facilities will be sent with a code number. Samples may be sent to other investigators not associated with this study to perform diagnostic testing (e.g., viral, fungal, bacterial and immunological). All samples will be provided to investigators not associated with the study without any identifiers and only contain a code number. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all lung transplant patients transplanted at UPMC
Criteria

Inclusion Criteria:

  • Patients who have undergone lung transplantation or will undergo a lung transplant at the University of Pittsburgh Medical Center and are alive following transplant period will be eligible for the study.

Exclusion Criteria:

  • Subjects not willing to participate in the research study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177918


Contacts
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Contact: EJ Kwak, MD 412-648-6401 kwakej@upmc.edu
Contact: Diana Pakstis, RN, BSN 412-648-6401 pakstisdl@dom.pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: EJ Kwak, MD    412-648-6489    kwakej@upmc.edu   
Contact: Diana Pakstis, RN, BSN, MBA    412-648-6553    dlp5@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: EJ Kwak, MD University of Pittsburgh Medical Center
More Information
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Responsible Party: EJ Kwak, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177918    
Other Study ID Numbers: IRB # 0212095
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Keywords provided by EJ Kwak, University of Pittsburgh:
Lung Transplant
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Infections
Bronchitis
Respiratory Tract Infections
 Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases